UK GLP Regulations

OECD Guidance on GLP Archives

EMEA Guidance for laboratories that perform analysis or evaluation of clinical trial samples (so called “GCLP”)


EudraLex – Volume 4: Good manufacturing practice (GMP) Guidelines – Chapter 4: Documentation

ICH Quality Guideline Q7: GMP Guidance for Active Pharmaceutical Ingredients
(refer to section 6)


EU Directive 2001/20 (Clinical Trials Directive) and Regulation 536/2014 (“New” Clinical Trials Regulation)

EU Directive 2005/28 (Good Clinical Practice)

Trial Master File Reference Model

Data Integrity

MHRA Guidance on GxP Data Integrity

Electronic records

FDA part 11 guidance for electronic records

International Research on Permanent Authentic Records in Electronic Systems

Model Requirements Specification for the Management of Electronic Records

Other associations

Information and Records Management Society (IRMS)

Information and Records Management Frameworks and Standards (compiled by IRMS)

The Research Quality Association

Archives and Records Association

Health Archives and Records Group (HARG)